Critical Care Products

We have launched and are developing a number of products which have applications in medical emergencies such as overdose, poisoning and life threatening infections. Typically such products sell for a high price and are targeted at specialist clinicians in the critical care setting.

CroFab™ [Crotalidae Polyvalent Immune Fab (Ovine)] and DigiFab™ [Digoxin Immune Fab (Ovine)] are both sold in the US by our marketing partner Fougera Inc, a division of Nycomed (previously Altana Inc). DigiFab™ is distributed in most mainland European countries by our licensee, Beacon Pharmaceuticals, and distributed in Germany and the Nordic countries by us.

We also potentially have two blockbuster opportunities in our critical care franchise. CytoFab™ is being developed by AstraZeneca for the treatment of severe sepsis, and has started an additional phase 2 study in January 2008. In addition, the Company has in-licensed the intellectual property from Glenveigh (a small private US based company) relating to the use of anti-digoxin polyclonal antibody fragments such as DigiFab™ and GSK’s Digibind® in the treatment of pre-eclampsia and eclampsia. Glenveigh has completed a phase 2b study with Digibind® and Protherics has reported the topline results (22nd April, 2008) but is still evaluating the data to assess its impact.

For more information on our critical care products please click on the product name.

Products

TECHNOLOGY USE STATUS PARTNER MARKET SIZE*
CroFab™
Ovine polyclonal antibody fragment (Fab) Minimal to moderate Crotalid (pit viper) envenomation Launched in US (2001);
Available on named patient basis within EU
Nycomed (US);
For other regions contact Protherics
Market potential estimated at up to US$70m in the US
DigiFab™
Ovine polyclonal antibody fragment (Fab) Treatment of life threatening digoxin toxicity or overdose Launched in US (2002); available on a named patient basis in EU;
UK approval expected in H2 2007 followed by approval in other EU member states; Marketing application submitted in Canada in Jan 2007
Nycomed (US); Beacon Pharmaceuticals (Europe excluding Scandinavia and Germany); Protherics (Scandinavia, Germany and other regions) Global market size estimated at US$30-35m
ViperaTAb™
Ovine polyclonal antibody fragment (Fab) Vipera berus (Common European adder) envenomation Sold on named patient basis in EU Swedish Orphan International AB (Scandinavia & Baltic countries); Protherics (rest of Europe) Market opportunity estimated at up to US$5m


Research and Development

TECHNOLOGY USE STATUS PARTNER MARKET
CytoFab™
Ovine polyclonal antibody fragment (Fab) Severe sepsis Encouraging phase 2b results. AZ has expanded phase 2 programme in January 2008 AstraZeneca Potential global market opportunity of up to ~$8bn for severe sepsis
Digoxin Immune Fabs (Digibind® (GSK) or DigiFab™)
Ovine polyclonal antibody fragment (Fab) Pre-eclampsia
and eclampsia
Phase 2b study in severe pre-eclampsia is ongoing in the US with Digibind® No partner US market worth up to $5bn
~$900m for severe pre-eclampsia

* Based on Protherics estimates

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